Actively Recruiting
Luspatercept for the Treatment of Anemia Following Allogeneic Hematopoietic Stem Cell Transplantation(Allo-HSCT)
Led by Zhujiang Hospital · Updated on 2026-01-23
46
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, single-arm, prospective exploratory study designed to evaluate the safety and efficacy of luspatercept for the treatment of anemia following allogeneic hematopoietic stem cell transplantation in patients with acute leukemia. A total of 46 eligible subjects are planned to be enrolled. The primary efficacy endpoint is the proportion of patients achieving a hemoglobin increase of ≥1.5 g/dL at 8 weeks post-transplantation (without transfusion support) compared to baseline (the average of 3 days prior to the first dose). Secondary endpoints include assessing the impact of luspatercept on time to hematopoietic engraftment (neutrophil and platelet) and recording safety indicators such as adverse events, graft-versus-host disease, and infections. Subjects will receive subcutaneous luspatercept at 1 mg/kg on day +7 and day +28 post-transplantation.
CONDITIONS
Official Title
Luspatercept for the Treatment of Anemia Following Allogeneic Hematopoietic Stem Cell Transplantation(Allo-HSCT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically diagnosed with acute leukemia.
- Have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- Expected to survive for more than 3 months from signing the informed consent.
- Willing and able to comply with scheduled visits, treatments, tests, and study procedures.
- Women of childbearing potential must have a negative serum pregnancy test before enrollment.
- Women who are surgically sterile or postmenopausal for at least 2 years are considered not of childbearing potential.
- Male and female subjects of reproductive potential must agree to use effective contraception during the study.
- Hemoglobin level below 80 g/L.
You will not qualify if you...
- Inadequate organ function including creatinine clearance below 60 mL/min, left ventricular ejection fraction under 55%, oxygen saturation below 92% on room air, total bilirubin above twice the upper normal limit, or ALT/AST over three times the upper normal limit.
- Poorly controlled hypertension despite therapy or history of hypertensive crisis or encephalopathy.
- History of other malignancies except acute leukemia unless disease-free for 5 years; certain skin and carcinoma in situ cancers are allowed.
- Major surgery within 8 weeks prior to enrollment without full recovery.
- History of stroke, transient ischemic attack, deep vein thrombosis, embolism, or thrombosis within 6 months prior to enrollment.
- Uncontrolled epilepsy or active central nervous system disorders.
- Cardiac disease within 6 months prior including myocardial infarction, uncontrolled angina, severe heart failure, or uncontrolled arrhythmia.
- Uncontrolled active fungal, bacterial, or viral infection.
- Evidence of HIV infection or active hepatitis B or C.
- History of pure red cell aplasia or anti-erythropoietin antibody.
- Any condition or medication interfering with study data interpretation.
- Known allergy to luspatercept or its ingredients.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zhujiang Hospital
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
Z
Zhao Liang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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